NCT03906812

Brief Summary

This study aims to determine, relative to telemetry admission, if admission to an unmonitored floor bed saves resources without an increased rate of adverse events in emergency department (ED) patients admitted with chest pain and low-risk features.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

1.6 years

First QC Date

April 5, 2019

Last Update Submit

November 7, 2019

Conditions

Telemetry UsageChest PainUnstable AnginaResource Utilization

Outcome Measures

Primary Outcomes (1)

  • Total hospital resource utilization (costs)

    Total cost of the acute hospitalization and use of diagnostic testing and therapies

    ED to discharge (approximately 1 to 5 days)

Secondary Outcomes (7)

  • Inhospital mortality

    ED to discharge (approximately 1 to 5 days)

  • Total number of serious dysrhythmias by type

    ED to discharge (approximately 1 to 5 days)

  • Provider reasons for telemetry exclusion

    ED to discharge (approximately 1 to 5 days)

  • Number of participants requiring transfer to the Intensive Care Unit (ICU)

    ED to discharge (approximately 1 to 5 days)

  • Total hospital and ED length of stay

    ED to discharge (approximately 1 to 5 days)

  • +2 more secondary outcomes

Study Arms (2)

Unmonitored floor admission

ACTIVE COMPARATOR

Participants in this arm will be admitted to an unmonitored floor bed.

Other: Unmonitored

Floor admission with telemetry

ACTIVE COMPARATOR

Participants in this arm will be admitted to a telemetry bed.

Other: Telemetry

Interventions

TelemetryOTHER

Bed type assignment

Floor admission with telemetry
UnmonitoredOTHER

Bed type assignment

Unmonitored floor admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ED patients admitted to the medical service at Vanderbilt University Medical Center with chest pain and low-risk clinical features.

You may not qualify if:

  • Age less than 18 years
  • Chest pain patients admitted to the ICU
  • Patients with sickle cell disease
  • Chest pain patients with high-risk electrocardiogram (ECG) criteria:
  • abnormal but non-diagnostic of myocardial ischemia (prolonged PR, QRS, QTc intervals, new bundle branch blocks, left ventricular hypertrophy with strain)
  • ischemia or prior infarction
  • suggestive of acute myocardial infarction
  • A positive troponin at any time during the current evaluation (above the 99 percent reference limit, greater than 0.03 nanograms per milliliter)
  • Patients whom the admitting team feels has another non-low-risk indication for telemetry (e.g. acute heart failure, syncope with features concerning for a cardiac etiology, other arrhythmia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (12)

  • Selker HP, Griffith JL, Dorey FJ, D'Agostino RB. How do physicians adapt when the coronary care unit is full? A prospective multicenter study. JAMA. 1987 Mar 6;257(9):1181-5.

    PMID: 3806915BACKGROUND

  • Ward MJ, Eckman MH, Schauer DP, Raja AS, Collins S. Cost-effectiveness of telemetry for hospitalized patients with low-risk chest pain. Acad Emerg Med. 2011 Mar;18(3):279-86. doi: 10.1111/j.1553-2712.2011.01008.x.

    PMID: 21401791BACKGROUND

  • Sandau KE, Funk M, Auerbach A, Barsness GW, Blum K, Cvach M, Lampert R, May JL, McDaniel GM, Perez MV, Sendelbach S, Sommargren CE, Wang PJ; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Cardiovascular Disease in the Young. Update to Practice Standards for Electrocardiographic Monitoring in Hospital Settings: A Scientific Statement From the American Heart Association. Circulation. 2017 Nov 7;136(19):e273-e344. doi: 10.1161/CIR.0000000000000527. Epub 2017 Oct 3.

    PMID: 28974521BACKGROUND

  • Goldman L, Weinberg M, Weisberg M, Olshen R, Cook EF, Sargent RK, Lamas GA, Dennis C, Wilson C, Deckelbaum L, Fineberg H, Stiratelli R. A computer-derived protocol to aid in the diagnosis of emergency room patients with acute chest pain. N Engl J Med. 1982 Sep 2;307(10):588-96. doi: 10.1056/NEJM198209023071004.

    PMID: 7110205BACKGROUND

  • Hollander JE, Valentine SM, McCuskey CF, Brogan GX Jr. Are monitored telemetry beds necessary for patients with nontraumatic chest pain and normal or nonspecific electrocardiograms? Am J Cardiol. 1997 Apr 15;79(8):1110-1. doi: 10.1016/s0002-9149(97)00057-x.

    PMID: 9114775BACKGROUND

  • Snider A, Papaleo M, Beldner S, Park C, Katechis D, Galinkin D, Fein A. Is telemetry monitoring necessary in low-risk suspected acute chest pain syndromes? Chest. 2002 Aug;122(2):517-23. doi: 10.1378/chest.122.2.517.

    PMID: 12171825BACKGROUND

  • Schull MJ, Redelmeier DA. Continuous electrocardiographic monitoring and cardiac arrest outcomes in 8,932 telemetry ward patients. Acad Emerg Med. 2000 Jun;7(6):647-52. doi: 10.1111/j.1553-2712.2000.tb02038.x.

    PMID: 10905643BACKGROUND

  • Reaney PDW, Elliott HI, Noman A, Cooper JG. Risk stratifying chest pain patients in the emergency department using HEART, GRACE and TIMI scores, with a single contemporary troponin result, to predict major adverse cardiac events. Emerg Med J. 2018 Jul;35(7):420-427. doi: 10.1136/emermed-2017-207172. Epub 2018 Apr 5.

    PMID: 29622596BACKGROUND

  • Estrada CA, Prasad NK, Rosman HS, Young MJ. Outcomes of patients hospitalized to a telemetry unit. Am J Cardiol. 1994 Aug 15;74(4):357-62. doi: 10.1016/0002-9149(94)90403-0.

    PMID: 8059698BACKGROUND

  • Estrada CA, Rosman HS, Prasad NK, Battilana G, Alexander M, Held AC, Young MJ. Role of telemetry monitoring in the non-intensive care unit. Am J Cardiol. 1995 Nov 1;76(12):960-5. doi: 10.1016/s0002-9149(99)80270-7.

    PMID: 7484840BACKGROUND

  • Hollander JE, Sites FD, Pollack CV Jr, Shofer FS. Lack of utility of telemetry monitoring for identification of cardiac death and life-threatening ventricular dysrhythmias in low-risk patients with chest pain. Ann Emerg Med. 2004 Jan;43(1):71-6. doi: 10.1016/s0196-0644(03)00719-4.

    PMID: 14707944BACKGROUND

  • Lee TH, Juarez G, Cook EF, Weisberg MC, Rouan GW, Brand DA, Goldman L. Ruling out acute myocardial infarction. A prospective multicenter validation of a 12-hour strategy for patients at low risk. N Engl J Med. 1991 May 2;324(18):1239-46. doi: 10.1056/NEJM199105023241803.

    PMID: 2014037BACKGROUND

MeSH Terms

Conditions

Chest PainAngina, Unstable

Interventions

Telemetry

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAngina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sean P Collins, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study statistician will be blinded to study arm assignment.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Comparative effectiveness - on admission, eligible, low-risk patients will be individually assigned to either unmonitored floor admission or floor admission with telemetry.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sean Collins, M.D., MSc, Professor

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 8, 2019

Study Start

September 1, 2020

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
Access Criteria
Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

Locations

US(1)